An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Antonio Hardan, Stanford University
ClinicalTrials.gov Identifier:
NCT01400269
First received: May 31, 2011
Last updated: January 13, 2014
Last verified: January 2014

May 31, 2011
January 13, 2014
September 2010
September 2015   (final data collection date for primary outcome measure)
Social Responsiveness Scale [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Outcome measure is the change from week 12 relative to baseline.
Same as current
Complete list of historical versions of study NCT01400269 on ClinicalTrials.gov Archive Site
  • Repetitive Behavior Scale [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.
  • Family Empowerment Scale [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.
  • Caregiver Strain questionnaire [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.
  • Pediatric Quality of Life Inventory [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.
  • Sensory Profile Questionnaire [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Outcome measure is the change from week 12 relative to baseline.
Same as current
Not Provided
Not Provided
 
An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism
An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism

The purpose of this study is to assess the efficacy of a parent training program in the treatment of social and communication deficits in children with autism. Specifically, this study will evaluate a developmentally based parent delivered intervention in the community developed by Pacific Autism Center for Education (PACE).

There are many treatments that claim to be effective for children with autism; however many of these treatments have not been investigated using scientifically rigorous methodology. A variety of developmentally based parent delivered interventions are gaining popularity as a type of treatment parents utilize to improve symptoms related to their child's diagnosis of autism. Pacific Autism Center for Education (PACE)is a agency that provides a developmentally based parent delivered intervention in the community. Currently, this parent training program has not been evaluated using scientific methodology. Investigation into this community delivered treatment and its effectiveness to improve social and communication deficits will aid clinicians in providing better care for children with autism.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autistic Disorder
Behavioral: Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
Experimental: Pacific Autism Center for Education (PACE)
Behavioral: Pacific Autism Center for Education (PACE) developmentally based parent delivered intervention
Intervention: Behavioral: Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
September 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • meets DSM-IV-TR criteria for an autism spectrum disorder (pervasive developmental disorder) on the basis of clinical evaluation and the research diagnostic methods
  • age range between 18 months and 6.11 years
  • male or female in good medical health
  • will be starting PACE parent training program
  • intends on continuing PACE program for a minimum of 12 weeks

Exclusion Criteria:

  • medically unstable (e.g., more than one seizure a month)
  • a medical diagnosis that causes autism like symptomology (e.g., Fragile X, Down syndrome, Angelman's syndrome, tuberous sclerosis, Rett's disorder)
Both
18 Months to 6 Years
No
Contact: Christina Ardel, MA (650) 736-1235 csmich@stanford.edu
United States
 
NCT01400269
SU-11022010-7169
No
Antonio Hardan, Stanford University
Stanford University
Not Provided
Principal Investigator: Antonio Hardan, MD Stanford University
Stanford University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP